Supporting Women With Breast Cancer to Prepare for Treatment (The Prepare Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Patient Anxiety
研究概览
简要总结
The purpose of this study is to evaluate if a brief mindfulness intervention before and after surgery would impact patient emotional wellbeing, quality of life, and biomarkers measured before and after surgery by finger prick collection and surveys.
详细描述
The purpose of this project is to evaluate a brief, technology-enabled mindfulness intervention before and following breast cancer surgery to determine its impact on emotional wellbeing and biological stress response in breast cancer patients. The investigators will administer self-reported questionnaires of emotional wellbeing and quality of life and collect pro and anti-inflammatory cytokines (CRP and IL-10, respectively) using a minimally invasive finger prick approach. The findings from this study will help establish an evidence base on the efficacy of a brief, technology enabled mindfulness intervention on patient anxiety, wellbeing and biological response. No previous studies have examined the impact of a brief mindfulness training prior to and following surgery on patient wellbeing. The long-term goal is to determine whether brief, technology-enabled mindfulness support can become part of routine preparation for breast cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females >20 and < 85 years of age
- •History of contralateral breast cancer in the past is acceptable
- •Patients seeking second opinion for diagnosis are eligible
- •Clinical AJCC stage 0-III breast cancer
- •Patients who have an in breast tumor recurrence are eligible
- •English Speaking
- •Willing to fill out surveys required for the study
- •Gene mutation carriers are eligible
- •Neoadjuvant therapy patients are eligible
排除标准
- •AJCC Stage IV breast cancer
- •Unwilling to fill out surveys for the study
- •Patients with a distant recurrence
- •Patients unaware of their diagnosis
研究组 & 干预措施
Mindfulness Arm
Brief video and audio practice of mindfulness
干预措施: Mindfulness Arm (Behavioral)
Health Videos - Mike Evans
Brief videos focusing on health and wellness
干预措施: Control group placebo (Other)
结局指标
主要结局
Patient Anxiety
时间窗: 3 months
To measure the impact of a mindfulness intervention instituted prior to surgery on patient anxiety for newly diagnosed breast cancer patients, using the PROMIS anxiety questionnaire \[Emotional Distress - Anxiety - Short Form 8a answer options are: Never, Rarely, Sometimes, Often, Always\].
次要结局
- Patient Depression(3 months)
- Psychosocial wellbeing(3 months)
- Stress biomarker(3 months)
研究者
Katharine Yao, MD
Principal Investigator
Endeavor Health